Evelo Biosciences, Inc. (NASDAQ:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered, systemically acting biologics, today announced that it has completed enrollment of 24 patients in the Phase 1b clinical trial cohort evaluating EDP1815 in mild to moderate atopic dermatitis. EDP1815 is an investigational oral biologic in development for the treatment of inflammatory diseases.
“Topical therapies are the mainstay of treatment for mild and moderate atopic dermatitis but patient satisfaction and compliance is low, as many find existing regimens too inconvenient or unsatisfactory to support long-term use,” said Benjamin Ehst, M.D., Ph.D., Board-certified Dermatologist, Investigator and Clinical Associate Professor with the Oregon Medical Research Center. “Similar to the unmet need in psoriasis, there is an urgent need for a new therapeutic option that can be delivered orally and has a clean safety profile to effectively treat a broad range of patients with atopic dermatitis. I am encouraged by early clinical and biomarker data in psoriasis, which have shown EDP1815 to be well-tolerated and active on systemic inflammation. I am hopeful that these data will be replicated in atopic dermatitis, where I believe EDP1815 could meaningfully change the treatment paradigm for millions of patients.”
“We are pleased to announce that we have completed enrollment in our Phase 1b cohort evaluating EDP1815 in atopic dermatitis ahead of schedule, and are grateful to the patients who are participating in the trial, especially in the midst of the ongoing COVID-19 pandemic,” said Duncan McHale, M.B.B.S., Ph.D., Chief Medical Officer of Evelo. “The fast pace of enrollment reflects the dissatisfaction with current treatment options and the substantial demand for a new therapy for atopic dermatitis, as well as Evelo’s commitment to executing with urgency to deliver on EDP1815’s full potential. A range of preclinical data in models of Th2-inflammation, combined with the promising clinical data we have already seen in patients with mild and moderate psoriasis, gives us confidence that we can deliver on the unmet need in atopic dermatitis. We look forward to announcing data early next year.”
EDP1815-101 is a double-blind, placebo-controlled Phase 1b trial designed to evaluate the safety and tolerability of EDP1815 in healthy volunteers and patients with psoriasis or atopic dermatitis. The atopic dermatitis cohort enrolled 24 patients with mild to moderate atopic dermatitis, randomized 2:1 to receive oral administration of 2.76g of the enteric capsule formulation of EDP1815 or placebo once daily, for 56 days. The primary endpoint is safety and tolerability. Secondary endpoints include key validated markers of atopic dermatitis, including the Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), Dermatology Life Quality Index (DLQI), and Pruritis Numerical Rating Scale (Pruritis NRS).